The use of condoms in ancient civilizations is a subject of much debate among archaeologists and historians. The oldest claimed representation of condom use is a 12,000 to15,000 year old painting in the French cave known as Grotte des Combarrelles. The Ancient civilizations of Rome, Greece, and Egypt typically had small families by the practice of a variety of birth control methods. Despite the fact that these societies at that time viewed birth control as a woman's responsibility there are references to male-controlled contraceptive methods, i.e. condoms, etc.
References in historical documents to condoms exist but are generally difficult to find. A major contributing factor to the loss of any significant contraceptive historical documentation was the rise of Catholicism which considers all forms of birth control to be a sin. Various Jewish and Muslim writings from the Middle Ages refer to attempts at other interesting if not imaginative male-controlled contraception, including such things as covering the penis in tar or soaking the penis in onion juice. It is well documented, however, that prior to the 15th century glans condoms (devices that cover only the head of the penis) were used as a means of birth control in Asia by members of the upper classes. The historical record indicates that glans condoms in China were typically made from oiled silk paper and/or lamb's intestines while the Japanese made them from tortoise shells or animal horns.
The first documented pandemic of syphilis began in Europe in 1494 and by 1505 had spread to China killing an unverifiable millions of people. It was during this pandemic that the use of a condom as a medical device, i.e disease barrier, first appears in the historical record. In 1564 Gabriele Falloppio authored De Morbo Gallico (referring to syphilis) wherein he recommended as a prevention of syphilis the use of a condom that he claimed to have invented. The Falloppio condom was comprised of linen sheaths soaked in a chemical solution and allowed to dry before use. The cloths were sized to cover the glans of the penis and were held on with a pink ribbon. The thought being that the pink ribbon would be more attractive for the ladies. Fallopio conducted what appears to be the first clinical trial of the efficacy of his condom device as a disease barrier on 1100 men and reported that “I call immortal God to witness that not one of them was infected.” After the 1564 publication of De Morbo Gallico the use of condoms to protect from disease is described in a wide variety of historically significant documents throughout Europe.
On Jul. 3, 1981, the New York Times broke the story on a new public health threat, an acquired immunodeficiency syndrome (AIDS). It was not until 1982, however, that it was first suggested that the disease was sexually transmitted. It was in response to these findings that the U.S. Surgeon General Dr. C. Everett Koop publically supported condom promotion programs as a means of AIDS transmission prevention.
Condoms and condom-like devices eventually would be used to assist in the medical and hygiene care of male patients affected by urinary incontinence. Ancient reports on urinary incontinence are rather rare and mainly address cases of extraurethral incontinence (e.g. due to a fistula acquired during childbirth) or overflow incontinence (e.g. in males with urinary retention or after spinal cord injury). In later centuries several authors dealt with the problem of postoperative incontinence after perineal lithotomy. Defined surgical techniques for the cure of urinary incontinence, however, were not introduced before the 19th century. First this was limited to fistula repair but by the end of the 19th century new procedures for stress incontinence were introduced and became standard clinical procedures. Other modern techniques, like artificial sphincters or electrostimulation, were alternatives developed in urology in the second half of the 20th century.
On the other hand the use of different catheters for the relief of urinary retention is described in many early cultures. Bloom D A, McGuire E J, Lapides J: A brief history of urethral catheterization. J Urol 1994; 151: 317-325. The first sources dealing briefly with urinary incontinence are Egyptian manuscripts from the 2nd millennium B.C. the “Papyrus Smith” and the “Papyrus Ebers”. Greek medicine was dominated by the outstanding work of Hippocrates (460-377 B.C.) who was writing extensively about the diseases of the urinary tract. Despite his discussion on perineal lithotomy Hippocrates also dealt extensively with urinary incontinence management.
The most famous surgeon of the Renaissance era, Ambroise Paré (1510-1590), had a great interest in the urinary tract and was one of the first surgeons to resect “carnosities” of the urethra. Paré described the alterations caused by subvesical obstruction and realized the mechanism of synchronized sphincter relaxation and detrusor contraction during micturition. Paré promoted the use of a portable urinal for incontinent males and an instrument that facilitates urination in the standing position after loss of the penis that looks remarkably similar to a modern condom catheter. In describing the use of this condom like device Paré is quoted as stating that “[t]hose that have their yards cut off close to their bellies, are greatly troubled in making urine, so that they are constrained to sit downe like women, for their ease. I have devised this pipe or conduit . . . that must be applied to the lower part of the os pectinis . . . serving instead of the yard in making of water, which therefore we may call an artificiall yard.”
Urinals designed to be worn and into which the male penis would partially extend have been known for centuries. For example Wilhelm Fabricius Hildanus (1560-1634) provided a modified urinal for the treatment of incontinence in his work “De ardore et incontinentia urinae, et nova inventione instrumenti, quo inter deambulandum colligitur” consisting either of a glass container or the bladder of a pig that was attached to the body by straps. U.S. Pat. No. 480,911 reveals that a worn urinal into which the penis is inserted for penile discharges have been known in the patent art in the United States at least from 1892.
In his book “Chirurgie” the German Lorenz Heister (1683-1758) dedicated two chapters on male and female incontinence: “Wenn Manns-und Frauens-Personen den Urin nicht halten können”. Besides the use of a urinal as described by Paré or Fabricius Hildanus, Heister suggested a penile clamp that was covered with leather and removed by the patient at the time of micturition. With reference to a colleague named Winslow, Heister designed a belt that produces perineal compression to the bulbar urethra.
The oldest device for external compression of the male urethra is the penile clamp. It was brought into use again by J. H. Cunningham as a helpful instrument for performing retrograde urethrography, a radiographic method that was introduced by him into urology in 1910, and is still named after Cunningham today. The first artificial sphincter that was designed as an inflatable circular cuff and applied to the male urethra by surgical means was created by Frederic E. B. Foley (1891-1966) from St. Paul, Minn. and published in 1947. This ingenious urologist is best known for the improvement of the principles of the transurethral balloon catheter and played a major role in the introduction of commercially manufactured balloon catheters in the 1930's.
The prior art is replete with examples of male urinary incontinence devices claiming to provide a satisfactory device for wear by men. Such a device should be: easily applied; comfortable; leak proof; remain securely attached over a considerable period of time without discomfort regardless of the activity level of the user; accommodating of a sudden surge flow of urine; hygienic; cost effective to manufacture; and be removable without pain or discomfort. The prior art devices fulfill some of these essentials but otherwise each are totally inadequate on others.
The use of external catheters, i.e. the condom or Texas catheter for treating male urinary incontinence is well known, as disclosed in U.S. Pat. Nos. 4,378,018, 4,187,851, 3,863,638, 3,835,857 and 4,475,910. These external urinary drainage means or condom catheters first appear in the patent literature in German Pat. No. 520.401. These condom catheters are typically comprised of an elastic sheath adapted to fit over the penis. The sheath is manufactured with an outlet at its distal end that can be connected to a tube or other collection means. The sheath is typically designed with a constricted downstream end portion adapted for fluid-tight connection with a drain tube. The sheath is usually comprised of a thin elastomeric fluid-impermeable material such as latex rubber or silicone rubber. This sheath is for all intents and purposes similar to a condom which can be rolled onto the penis.
The prior art teaches several attachment means for condom catheters to the penis which include non adhesive and adhesive catheters. Non-adhesive condom catheters are held in place with either an inflatable ring such as the Cook Non-Adhesive Silicone Condom Catheter or a Velcro strap that can be wrapped around the sheath. These types of condom catheters are typically reusable.
The most popular condom catheter in use today are the one piece self-adhesive condom catheters. These condom catheters are easier to put on by rolling it over the shaft of the penis and then by pressing the catheter against the skin to help the adhesive to stick to the penis. Recent condom catheters are typically made entirely of silicone since it has been reported that these types of condom catheters are less likely to cause skin irritation or cause other adverse reactions. These of course are a good alternative for those in men with a latex allergy or sensitivity. A variation of these types of one piece condom catheters is the current art AlphaDry condom catheter which consists of a one way valve and a small reservoir that can be stored in a user's underwear.
Also available in the current art are two piece condom catheters which consist of a sheath and separate hydrocolloid strips. These hydrocolloid strips have adhesive surfaces on both the inside and outside. The hydrocolloid strips are first wrapped around the penis. The condom catheter is then rolled up the penis toward the abdomen over the strips and once unrolled it is then pressed to stick against the hydrocolloid strips that is adhered to the penis. A significant problem exists with this type of condom catheter because many users apparently will put on the strips in a way that is too tight for the penis causing irritation, restriction of blood flow and in some extreme cases, necrosis.
The Liberty Pouch™ is a small external flower shaped wafer that is applied and sealed to the penis tip. The Liberty Pouch™ is made of a hydrocolloid material and covered by a second layer of material that wraps around the glans or head of the penis for protection. The outside of the Liberty Pouch™ is designed to direct expelled urine into a tube for collection in a bag typically stored in the underwear or pants of a user. The Liberty Pouch™ is beneficial for men with either a short or retracted penis and also for un-circumcised men. The foreskin of the un-circumcised penis is retracted to allow application of the device and then brought forward to cover it. There are a large variety of external pouch types of condom catheters available. Because these pouch type condom catheters typically are adhered directly to the skin a user needs to remove the pubic hair surrounding the base of the penis often resulting in skin irritation.
It is well known in the art that using external condom catheters can cause a variety of serious problems for the user. These problems include skin irritation, maceration of the penis tip, urinary tract infections (UTI), ischemia and penile edema or urethral obstruction. Many of these complications occur frequently when the catheter: is not put on correctly; is used for longer than recommended; causes skin to be constantly wet which often softens the skin which eventually will be worn away by the condom catheter. Skin barrier products are often used prior to the application of the condom catheter to protect the skin from constant wetness but these have proven to be ineffective in preventing these potentially life threatening conditions.
The use of adhesive straps, especially with the condom catheters with adhesive on both sides, is known to cause strangulation of the penis or to excessively constrict it. Condom catheters are also known to cause infections which typically stems from the fact that all current art condom catheters are ineffective in preventing urine from accumulating and remaining against the penis and often times the urethra. Current art condom catheters are designed to prevent leakage of urine but at the same time they also prevent air from reaching the skin which would permit the urine to drain and prevent anaerobiosis of urinary tract infectious agents. The skin of a user can also break down with minor erosion and dermatitis resulting from lack of air and presence of urine.
It has been suggested that clear silicone condom catheters allow a user to see their skin condition while they are worn and also allow some oxygen and water vapor to reach the skin. This is largely anecdotal and would depend upon the fit of the condom catheter. Even with more rigid clear silicone condom catheters the buildup of urine occurs especially if the condom catheter fits more snuggly on the penis.
Backflow leakage is a persistent problem in condom catheters as well resulting from fluid backflow between the penis and the sheath of the condom. In an attempt to resolve this problem the prior art teaches the interposing of a sealant pad between the sheath and the penis as disclosed in U.S. Pat. Nos. 4,187,851 and 4,378,018. The consequences of the backflow of urine are well known, urinary tract infections, sores, discomfort and other related problems. Sealant pads are designed to prevent leakage and to retain the catheter in place. It is well known in the art that there are significant problems with this design in fitting these pads and catheters on the penis exactly as intended. The pad depicted in U.S. Pat. No. 4,187,851 for example is comprised of an adhesive strip intended to be wrapped around the penis before the condom catheter is unrolled into position. This process is difficult if not impossible for most patients suffering from urinary incontinence since they often lack the ability to undertake such intricate maneuvers. Attending medical personnel are often unable or unwilling to take the time necessary for properly wrapping and molding the sealant pads in place, and then carefully fitting the sheaths over the pads to form the necessary leak proof seal. Additionally the problems that may result from the improper application of such a condom catheter often are more serious than backflow leakage or patient discomfort, i.e. urinary tract infections and sores. In the event an adhesive pad as shown in U.S. Pat. No. 4,187,851 is wrapped too tightly around the penis, circulation might be impaired and tissue necrosis could result.
Condom catheters are also available with an internal coating of pressure sensitive adhesive eliminating the need for using a separate adhesive-coated sealant pads, as depicted in U.S. Pat. No. 4,475,910. This composition does appear to avoid some of the serious dangers that have been associated with the wrap around sealant pads described above, however, the known difficulties of applying these types of condom catheters coupled with the problem of leakage resulting from improper application persist and they may even be worse. Inordinate care is necessary when unrolling these types of adhesive coated condom catheters over the penis to make certain that the condom catheter is evenly applied without wrinkles or flow channels. Making matters worse many users while trying to handle these condom catheters frequently experience the adhesive coated inner surface coming into contact with each other and sticking together during application of the catheter. Separation of these surfaces after they have stuck together is virtually impossible. The result often prevents any corrective steps being taken and leakage of the condom catheter is for all intents and purposes a certainty.
U.S. Pat. No. 4,589,874 teaches the use of a condom catheter that has an inner sleeve designed to be stretched about the glans of the penis to prevent backflow and protect the delicate skin from injury that may be caused by long-term contact with residual urine that may remain near the outlet end of the sheath when the catheter is used. Whether these catheters are held in place by adhesive coating or an adhesive pad, they all require for proper placement of the inner sleeve into a fluid-tight contact with the glans portion of the penis before the proximal portion of the condom catheter may be adhesively secured to the penis. Again, this is a major difficulty in the use of these types of condom catheters and consequently are particularly unpopular.
Attempts have been made as shown in the prior art to try and resolve the backwash effect by introducing various means of removing accumulated urine by various means such as wicking fibers. For instance U.S. Pat. No. 4,820,289 discloses a condom catheter flocked with particles of fiber. This disclosed flocked external condom catheter is comprised of a sheath adapted to fit over the penis with a constricted downstream end portion adapted for a fluid-tight connection with a drain tube. One of the surfaces disclosed in this patent is comprised of a thin layer of adhesive and a uniform layer of small particles of a bonded fabric.
Other prior art patents of generally relating to condom catheters are U.S. Pat. Nos. 4,022,213, 4,284,079, 3,405,714, 4,239,044, 3,353,538, 3,511,241, 3,721,243, 3,631,857, 3,788,324, 3,339,551, 3,364,932, 4,296,502, and 3,742,953.
The prior art condom catheters, while partially effective in aiding male suffering with incontinence, as disclosed above, each have a number of significant problems such as:                1) Attachment by adhesive which is difficult to obtain an effective seal without channeling issues occurring and causing a serious skin irritation and damage upon removal for many users;        2) Difficulty in applying and removing the condom catheter without injuring the penis;        3) Difficulty in securely attaching the condom catheter to a user such that it remains functional, despite activity and a flaccid condition of the penis; and        4) Accumulation of urine that causes irritation and urinary tract and other types of infections.        
There are no prior art condom catheters that solve all of these problems. Therefore there is a great need for a condom catheter device that is easily donned and remains securely in place regardless of the activity level of the user. Furthermore, to solve the problems of the prior art devices this condom catheter must also effectively facilitate the aspiration of backwashed urine that may accumulate between the penis and the condom catheter that is unable to drain from the distal or discharge end of the condom catheter. My invention is designed to solve these problems that exist in the current art.